The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda Tec 7 Anesthesia Vaporizer.
| Device ID | K012924 |
| 510k Number | K012924 |
| Device Name: | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | DATEX-OHMEDA, INC. P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | Bill Exner |
| Correspondent | Bill Exner DATEX-OHMEDA, INC. P.O. BOX 7550 Madison, WI 53707 -7550 |
| Product Code | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-31 |
| Decision Date | 2002-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682111454 | K012924 | 000 |
| 00840682111324 | K012924 | 000 |
| 00840682111508 | K012924 | 000 |
| 00840682111614 | K012924 | 000 |
| 00840682111744 | K012924 | 000 |
| 00840682111751 | K012924 | 000 |
| 00840682111300 | K012924 | 000 |
| 00840682111003 | K012924 | 000 |
| 00840682111393 | K012924 | 000 |
| 00840682111317 | K012924 | 000 |